This limited competition FOA is to continue the Alzheimer's
Disease Cooperative Study (ADCS) as the pre-eminent Alzheimer's disease (AD)
clinical trials consortium. The purpose of this FOA is to solicit the renewal
application for the next 5-year cycle of the ADCS. The goals of this
next phase are to continue to advance research in the development of
interventions that might be useful for treating, delaying, or preventing AD,
particularly interventions that might not be developed by industry.

Key Dates

Posted Date

November 28, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

March 7, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June - July 2012

Advisory Council Review

October 2012

Earliest Start Date(s)

December 1, 2012

Expiration Date

March 8, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the PHS398
Application Guide except where instructed to do otherwise (in this FOA or
in a Notice from the NIH Guide
for Grants and Contracts). Conformance to all requirements (both in
the Application Guide and the FOA) is required and strictly enforced. While
some links are provided, applicants must read and follow all application
instructions in the Application Guide as well as any program-specific
instructions noted in Section IV. When
the program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.

The Alzheimer's Disease Cooperative Study (ADCS; see
http://adcs.org/) was initially funded in1991 as a cooperative agreement
between the NIA and the University of California, San Diego (UCSD) in response
to the need to advance research in the development of interventions that might
be useful for treating patients with AD, particularly interventions that might
not be developed by industry. These include testing interventions to improve
cognition, slow the rate of decline, or delay the appearance of AD; developing
studies for promising interventions designed to ameliorate behavioral
symptoms; designing new instruments for use in clinical studies; developing
novel and innovative approaches to AD clinical trial design and analysis;
expanding the range of impairment level of patients studied in AD studies; and
enhancing the recruitment of minority groups into AD studies. The ADCS was
funded in response to RFA-AG-91-10 and the currently funded investigators have
developed the ADCS into the pre-eminent AD clinical trials consortium in the
U.S. There are currently 35 consortium member sites and more than 50 participating
sites, as well as productive and efficient Administrative, Data, Clinical
Operations, Medical, Imaging, and Biomarker Cores based at UCSD. There has
been widespread sharing of assessment tools, trial methods, and data with
investigators around the world.

Since 1991, the ADCS has initiated 30 research studies: 23
drug studies (Phase I-III) and 7 instrument development protocols. In addition
to conducting its own studies, the ADCS provides infrastructure support to
other federally funded clinical research efforts, including the Alzheimer's
Disease Neuroimaging Initiative (ADNI), the Dominantly Inherited Alzheimer
Network (DIAN), and investigator initiated R01 trials such as Nerve Growth
Factor (NGF) gene therapy trial. The number of participants enrolled has
ranged from 9 to 800 people per study with well over 7,000 participants
enrolled to date. The ADCS has generated numerous publications and a number of
the ADCS trials have had major public health impact. For example, the mild
cognitive impairment (MCI) donepezil/vitamin E trial was the first MCI trial
and the first trial to demonstrate delay of progression to AD with donepezil
treatment. In addition to the MCI trial, other trial design and analysis
innovations include the use of brain imaging endpoints in MCI and AD trials,
endpoint analyses in AD trials, linear modeling methods, and site performance
analysis. Instrument development for AD clinical trials also has been a focus
of the ADCS. The ADCS has developed instruments that have been widely used by
both academic and industry investigators around the world including the
Modified ADAS-cog with the addition of executive functioning and delayed
recall; the ADCS-ADL – first Activities of Daily Living (ADL) scale
specifically developed for AD; the ADCS-MCI-ADL – ADL scale for MCI trials; the
SIB - Severe Impairment Battery; and the ADCS-CGIC – standardized Clinical
Global Impression of Change scale. Currently, instruments for home-based
assessment for primary prevention trials are under study including mail-in
instruments, home computer instruments, and interactive voice response
instruments. Data and specimens collected during ADCS studies are shared with
external investigators. Data are typically shared by granting temporary access
to a study-specific web portal for download of the full data set, data
dictionary and supporting documents.

Purpose

The purpose of this FOA is to solicit the renewal application
for the next five-year cycle of the ADCS. The goals of this next phase
are to continue to advance research in the development of interventions that
might be useful for treating, delaying, or preventing AD, particularly
interventions that might not be developed by industry.

Research Objectives

The objectives for the next 5-year cycle of the ADCS are
listed below. The applicants are not expected to address all the research
objectives; if all research objectives are addressed, applicants are not
expected to address them evenly. The applicants are encouraged to balance
among these and justify their priorities and focus.

Test interventions to improve cognition, slow the rate of
decline, or delay/prevent the onset of AD.

Develop studies for promising interventions designed to
ameliorate behavioral symptoms.

Expand the range of individuals studied in AD studies to
include at-risk individuals and those with MCI.

Enhance the recruitment of minority groups into AD studies.

The applicants are not expected to address all the competing
scientific goals and research objectives evenly. The applicants are encouraged
to balance among these and justify their priorities and
focus.

The applicants should provide a multidisciplinary
organization and management structure appropriate for a mature yet constantly
innovating clinical trials consortium.

Section II. Award Information

Funding Instrument

Cooperative Agreement

Application Types Allowed

Renewal

The OER
Glossary and the PHS398 Application Guide provide details on these application
types.

Funds Available and Anticipated Number of Awards

NIA intends to commit up to $13 Million in FY2013. Future
year amounts will depend on annual appropriations and will be no more than $55
Million over 5 years.

Award Budget

Application budget is limited to $55 Million in Total
Costs.

Award Project Period

The maximum period is 5 years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

The applicant institution must have the facilities to
support multiple cores and to coordinate research at multiple sites both
nationally and internationally.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the PHS398 Application Guide to be eligible to apply for or
receive an award. Applicants must have a valid Dun and Bradstreet Universal
Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to
the current PHS 398 application forms in accordance with the PHS 398
Application Guide.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the PHS398
Application Guide, except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Not Applicable

Application Submission

Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:

All page limitations described in the PHS398 Application
Guide must be followed, with the following requirements:

The Research Strategy Section of the Overall Project Objectives
is limited to 6 pages.

The Research Strategy Section of proposed Cores is limited to 6
pages.

Each Project Section should be a maximum of 12 pages.

How to Organize the Application

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions:

Section 1: Information for the Entire Application

Form Page 1 - Face Page: Include the number and title of
this FOA in item/line 2 of the PHS 398 face page

Table of Contents: Modify PHS Form Page 3 to enable
reviewers to find each component of the application easily. Number all pages
consecutively. Because the first page of the application is the Title Page
begin the next page with the numeral "2". Do not use lettered numbers
(e.g., "2A", "2B" etc.) Use these referent numbers in the
Table of Contents.

Form Pages 4 and 5 Detailed Budget for Initial Budget
Period; Budget for Entire Proposed Period of Support: Prepare a detailed composite
budget (across all subprojects and cores) for all requested support categories
for the first year using Form Page 4 and a summary budget for the entire
proposed period of support using Form Page 5 of the PHS 398 application. If
applicable, provide additional budget pages for consortium/contractual
arrangements

Biographical Sketches

When an investigator has a role in more than one part of the
application then a complete biosketch should be placed in each section where
the individual has a role. As the particular qualifications for roles may
differ between cores and subprojects or between different subprojects, the
selected publications and the description of qualifications for the individual
may differ in the several biosketches listed.

Resources

Reviewers will use information from the Resources page to
evaluate the quality of the scientific environment for the research proposed.
Applicants should complete separate Resources pages for all projects and cores.
Reviewers will use information from the Resources page of the Administrative
Core to evaluate the quality of the overall environment for the consortium.

Section 2: Overall Program Objectives:

Specific Aims: (limited to one page): Describe the
aims of the overall project and outline how the component projects and cores
will contribute to these aims.

Overall Research Strategy: limited to 6 pages.

Items 1, 2 and 3 below are to be included in the six page
limit.

1. Significance: Focusing on the project as a whole address
(i) the importance of the problem or critical barrier to progress in the field
that the proposed project addresses, (ii) how the proposed project will improve
scientific knowledge, technical capability, and/or clinical practice in one or
more broad fields, (iii) how the concepts methods, technologies, treatments,
services, or preventive interventions that drive this field will be changed if
the proposed aims are achieved. (One to two pages recommended).

2. Innovation: Considering the project as a whole, show how
the proposed research seeks to shift current research or clinical practice
paradigms through use of novel concepts, approaches, methodologies,
instrumentation, or interventions. Are these concepts, approaches,
methodologies, instrumentation, or interventions novel to the research field or
novel in a broad sense? Does the proposed work refine, or improve, or apply in
a new way, the concepts, approaches, methodologies, instrumentation, or
interventions proposed?(One page recommended).

3. Approach: Include the major approaches and studies
involved in the application showing how the approaches of cores and individual projects
complement each other or are inter-dependent. Describe the mechanisms that will
ensure the coherence of the overall project and maintain a multidisciplinary
focus. (Three to four pages recommended.)

Renewals: Describe findings (with citations) from the prior
period of support that are of particular significance to the project as a
whole. If cores included in the prior period of support are not part of the current
submission describe their progress and explain why they are not included. In
addition in the Statement of Overall Program Objectives show the correspondence
between the structure of the renewal application and the prior application.
(Note: This should also be within the 6 page limit.)

Human Subjects

List the components of the application that involve human
subjects and page numbers for the relevant human subjects sections. In other
words, it is requested that the applicant list all the page numbers, where human
subjects are used, in sequential order.

Describe the composition of the human subjects and the
proactive plan to recruit women, minorities, and children (if appropriate).
List the page numbers for the relevant Women, Minorities, and Children
sections. For most NIA applications involving human participants, a justifiable
exclusion for children is that the topic is not relevant to children. See PHS Form 398 instructions.

Section 3: Research Strategies for Individual Cores and Component
Projects

How to organize the Layout of the Cores and Component Projects

Present information for each component project and core
according to the Table of Contents

List individual research projects in the application after
the cores, and identify them with consecutive Arabic numbers and titles
(project 1, project 2, etc.) Include the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) name, or Core Leader's (CL) name at the upper
right-hand corner of each page under the PD(s)/PI(s) name. Begin each component
project or core with a new PHS 398 Continuation Page. Do not use the Face Page
of PHS Form 398.

How to Organize Cores

Follow instructions in the PHS 398 form with the following
exceptions:

Specific Aims: (1 page)

Identify which subprojects the core will assist and indicate
the overall role of the core in the program project.

Research Strategy (6 pages)

Organize the Research Strategy into sections on: a.
Significance; and b. Approach

How to Organize Projects

Follow instructions in the PHS 398 form with the following
exceptions:

Specific Aims: (limited to 1 page)

Research Strategy: (12 pages)

Following Instructions in the PHS 398 form, the Research
Strategy should be organized into sections on: a. Significance; b. Innovation; and
c. Approach.

Research Plan

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies; GWAS) as provided in the PHS398
Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix (please note all format requirements) as
described in the PHS398 Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by components of participating organizations,
NIH. Applications that are incomplete and/or nonresponsive will not be
reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral research
are evaluated for scientific and technical merit through the NIH peer review
system.

For this particular announcement, note the following:

Reviewers will provide an overall impact rating to reflect
their assessment of the likelihood for the ADCS renewal considered as a whole
to continue to advance research in the development of interventions that might
be useful for treating, delaying, or preventing AD, considering the following
five scored review criteria, and additional review criteria (as applicable for
the project proposed).

They will give weight both to the merits of the individual
projects and cores and to the extent to which the renewal advances the aims of
the overall project. The criteria below will guide their assessment of the
overall impact of the renewal application as a whole. An application does not
need to be strong in all categories to be judged likely to have major
scientific impact. For example, a project that by its nature is not innovative
may be essential to advance a field.

Projects: Reviewers will provide an impact rating to reflect
their assessment of the likelihood that each component project will advance
research in the development of interventions for AD considering the five core
review criteria below.

Cores: Overall Impact: Reviewers will provide an adjectival
rating of high, moderate, or low enthusiasm. Central ("Core") Review
Criteria: Reviewers will consider four of the five review criteria below in the
determination of scientific and technical merit. As cores are generally
resources to enable or to advance research, “Innovation” is not considered
routinely as an independent review criterion for cores. Innovative cores may be
valuable and that value will be assessed under Significance or Approach as
appropriate.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the ADCS renewal to exert a sustained, powerful influence on the research field(s) involved, in consideration
of the following review criteria and additional review criteria (as applicable
for the overall project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the ADCS renewal address an important problem or
a critical barrier to progress in the field? If the aims of the overall project are achieved, how will scientific knowledge, technical capability, and/or
clinical practice be improved? How will successful completion of the aims
change the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the overall project? If Early Stage Investigators or
New Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD(s)/PI(s), do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?

If the overall project involves clinical research, are the plans for 1)
protection of human subjects from research risks, and 2) inclusion of
minorities and members of both sexes/genders, as well as the inclusion of
children, justified in terms of the scientific goals and research strategy
proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria - Overall

As applicable for the overall project proposed, reviewers
will evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed overall project involves clinical research, the committee will evaluate the proposed plans for
inclusion of minorities and members of both genders, as well as the inclusion
of children. For additional information on review of the Inclusion section,
please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

Not Applicable.

Additional Review Considerations - Overall

As applicable for the overall project proposed, reviewers
will consider each of the following items, but will not give scores for these
items, and should not consider them in providing an overall impact/priority
score.

Applications from Foreign Organizations

Not applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s)convened by the National Institute on Aging (NIA), in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will
compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications
will receive a second level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD(s)/PI(s) will be able to access his or her Summary Statement (written
critique) via the eRA Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility resides
with the awardees for the project as a whole, although specific tasks and
activities may be shared among the awardees and the NIH as defined below.

The
PD(s)/PI(s) will have the primary responsibility for:

overall management of the study through the coordinating center
and should agree to work cooperatively with the cores/functions and clinical
sites

developing and implementing systems necessary for communications
among the various study organizational components. The coordinating center will
facilitate the design and refinement of all protocols, manuals of operations,
and forms.

all data and samples that shall be placed in the public domain
and shared freely by methods and within time periods to be specified by the
Steering Committee, as a fundamental purpose of this study is the establishment
of an unrestricted public database.

Awardees will retain custody of and have primary rights to the
data and software developed under these awards, subject to Government rights of
access consistent with current DHHS, PHS, and NIH policies.

NIH
staff have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below:

The designated NIA Project Scientist will serve as a member of
the Steering Committee and have substantial scientific/programmatic involvement
during conduct of this cooperative agreement, through technical assistance,
advice, and coordination above and beyond normal program stewardship of grants.
The awardee agrees to accept assistance from the designated NIA Project
Scientist. This person will participate, through the Steering Committee, in the
monitoring of issues relating to recruitment, follow-up, and adherence to
protocols and will assist in the development and/or adjustment of study
protocols.

Additionally, an agency program official or NIA program director
will be responsible for the normal scientific and programmatic stewardship of
the award and will be named in the award notice.

Areas
of Joint Responsibility include:

The Steering Committee, comprised of the PD(s)/PI(s) of the
cooperative agreement, the leaders of the cores/functions and each of the
clinical sites, the bioethicist, the family representative, the FDA
representative, and the NIA Project Scientist will have primary responsibility
for finalizing standard definitions, procedures, and measures common for all
the protocols. The steering committee will meet every three to six months, or
as dictated by the needs of the study. Each full member of the Steering
Committee will have one vote, and all major scientific decisions will be
determined by majority vote of the Steering Committee. Awardee members of the
Steering Committee will be required to accept and implement policies approved
by the Steering Committee. Subcommittees appointed by the Steering Committee,
comprised of appropriate staff from the cores and clinical sites, will be
involved in the design of protocols and manuals of operations, and in ongoing
functions of the study such as preparation of publications.

To oversee the allocation and distribution of biological
specimens generated from the study, the Steering Committee will nominate
members for the Resource Allocation Review Committee (RARC). This group will
review applications for use of the biological specimens. The format of the
application and criteria for the use of repository biological specimens will be
developed by the RARC with advice and approval from the Steering Committee and
made available to all potential users. Membership on this committee will rotate
periodically according to a procedure developed by the RARC. Final approval of
members of the RARC and final approval for disposition of samples to
investigators following RARC review will be made by NIA staff. The primary
governing body of the study will be the Steering Committee, which will have
responsibility for the final details of study design and policy decisions and
will define the rules regarding access to data and samples.

Dispute
Resolution:

Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
composed of three members will be convened. It will have three members: a
designee of the Steering Committee chosen without NIH staff voting, one NIH
designee, and a third designee with expertise in the relevant area who is
chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special dispute resolution
procedure does not alter the awardee's right to appeal an adverse action that
is otherwise appealable in accordance with PHS regulation 42 CFR Part 50,
Subpart D and DHHS regulation 45 CFR Part 16.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII.
Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.